Peptide education
Sincalide
Kinevac · CCK-8
Sincalide is a synthetic fragment of cholecystokinin used during diagnostic procedures. Given intravenously, it can stimulate the gallbladder, pancreatic secretion, or movement of a barium meal through the small intestine.
Sincalide is a clinician-administered diagnostic agent. The dose and timing depend on whether the goal is gallbladder imaging, pancreatic testing, or small-bowel transit.
Overview
Quick answer
Kinevac's label describes different doses and infusion times for different procedures. A gallbladder imaging study tested a separate 60-minute infusion method and derived a reference range for that method.
What is sincalide used for?
The Kinevac label describes adult diagnostic use to contract the gallbladder, stimulate pancreatic secretion with secretin, or speed barium through the small bowel during imaging.
How is it administered?
Kinevac is reconstituted and given intravenously. The label specifies different weight-based doses and injection or infusion times for each diagnostic purpose.
What is a gallbladder ejection fraction?
It is a measure of gallbladder emptying during imaging. In a study of 60 healthy volunteers, a 60-minute sincalide infusion gave less variable measurements than 15- or 30-minute infusions.
What safety issues matter before a procedure?
Kinevac is contraindicated with intestinal obstruction or a history of hypersensitivity to sincalide or sulfites. Abdominal pain and nausea are common, and the label warns about gallstone movement and pregnancy risks.
Evidence
Evidence snapshot
The label covers gallbladder contraction, pancreatic secretion with secretin, and barium transit.
Three durations were compared using the same 0.02 mcg/kg dose during gallbladder imaging.
The study's lower reference limit applies to its 60-minute infusion and measurement method.
The label contraindicates use with intestinal obstruction or a history of hypersensitivity to sincalide or sulfites.
Claims
Common claims vs evidence
| Claim | Human evidence | Mechanistic evidence | Verdict |
|---|---|---|---|
| Sincalide helps measure gallbladder emptying. | In a multicenter study of healthy volunteers, sincalide was infused during imaging to calculate gallbladder ejection fraction. The 60-minute method produced the least variable measurements among those tested. | Sincalide stimulates gallbladder contraction. | Supported as a diagnostic stimulus; the imaging method affects the result. |
| Every gallbladder study uses the same sincalide infusion. | The study compared 0.02 mcg/kg over 15, 30, and 60 minutes. The Kinevac label also describes a different infusion amount and duration for gallbladder contraction. | Dose and timing must be read with the specific procedure and protocol. | |
| A 38% ejection fraction is a universal diagnostic cutoff. | The 38% lower reference limit came from healthy volunteers receiving 0.02 mcg/kg over 60 minutes, with measurement at the end of that infusion. | The reference belongs to that method and does not by itself establish a diagnosis. |
Bottom line
Main takeaway
Sincalide temporarily stimulates digestive organs so their response can be assessed during a procedure.
Sulfite sensitivity, bowel obstruction, gallstones, pregnancy, and medicines affecting gallbladder movement matter to the clinical team.
The healthy-volunteer ejection-fraction reference was derived using a specific 60-minute infusion.
Identity
What it is
Sincalide is an eight-amino-acid fragment of cholecystokinin. It reproduces effects of the natural hormone on gallbladder contraction, pancreatic secretion, and intestinal movement.
Kinevac comes as powder in a single-dose vial for reconstitution before intravenous administration.
Use context
Routes, doses, and cycle patterns
The labeled adult schedules vary by diagnostic purpose. The separate gallbladder imaging study compared infusion durations using a lower total dose than the label's alternative 50-minute gallbladder infusion.
Human studies and product labels
Gallbladder contraction label
- Purpose
- Stimulate gallbladder contraction for diagnostic assessment
- Context
- US prescribing label for adults
- Route
- Intravenous injection or infusion
- Amount
- 0.02 mcg/kg by injection; an alternative infusion uses 0.12 mcg/kg
- Frequency
- Single procedure administration
- Duration
- Injection over 30 to 60 seconds; alternative infusion over 50 minutes
The label permits a 0.04 mcg/kg injection if contraction is inadequate after 15 minutes. The slower alternative is described to reduce gastrointestinal reactions.
Pancreatic secretion label
- Purpose
- Stimulate pancreatic secretion with secretin for diagnostic sampling
- Context
- US prescribing label for adults
- Route
- Intravenous infusion
- Amount
- Sincalide 0.02 mcg/kg alongside the specified secretin infusion
- Frequency
- Single procedure administration
- Duration
- Sincalide over 30 minutes, starting 30 minutes after secretin begins
The label specifies secretin 0.25 units/kg over 60 minutes.
Barium transit label
- Purpose
- Accelerate small-bowel transit during imaging
- Context
- US prescribing label for adults
- Route
- Intravenous injection or infusion
- Amount
- 0.04 mcg/kg by injection; an alternative infusion uses 0.12 mcg/kg
- Frequency
- Given after the barium meal passes the proximal jejunum
- Duration
- Injection over 30 to 60 seconds; alternative infusion over 30 minutes
The label permits a second 0.04 mcg/kg injection if transit remains inadequate after 30 minutes.
Gallbladder ejection fraction study
- Purpose
- Compare variability of gallbladder emptying measurements
- Context
- Multicenter study in healthy volunteers
- Route
- Intravenous infusion
- Amount
- 0.02 mcg/kg on each study day
- Frequency
- Separate imaging visits comparing three infusion durations
- Duration
- 15, 30, or 60 minutes
The 60-minute method had the lowest variability and a 38% lower reference limit in the studied volunteers.
What varies
- Infusion method: dose and timing affect ejection-fraction measurements and their reference range.
- Medication review: drugs that alter gallbladder movement can interfere with the response.
- Procedure setting: Kinevac is reconstituted for intravenous administration and can cause immediate adverse reactions.
Research
Research evidence
The healthy-volunteer imaging study compared the variability of three sincalide infusion durations. The Kinevac label separately describes clinical diagnostic uses, adult administration schedules, and safety.
| Study / evidence area | Population | Design | Product context | Main outcome | Limitations | Weight |
|---|---|---|---|---|---|---|
| Gallbladder infusion-method study | 60 healthy volunteers at four medical centers | Multicenter comparison of 15-, 30-, and 60-minute infusions on separate days | 0.02 mcg/kg sincalide during gallbladder imaging | The 60-minute method had the lowest variability and a 38% lower ejection-fraction reference limit. | The reference was derived in healthy volunteers and is specific to that infusion and measurement method. | Moderate for method selection |
| Kinevac prescribing information | Adults undergoing specified diagnostic procedures | FDA prescribing information | Intravenous diagnostic agent | The label describes distinct schedules for gallbladder contraction, pancreatic secretion, and barium transit. | Safety and effectiveness have not been established in pediatric patients. | Strong for labeled procedure instructions |
Cautions
Safety and unknowns
- Kinevac is contraindicated in intestinal obstruction and in people with a history of hypersensitivity to sincalide or sulfites. The formulation contains a sulfite and serious allergic reactions, including anaphylaxis, have occurred.
- Abdominal discomfort or pain and nausea are common. The label notes that gallbladder contraction can move small stones into a bile duct.
- The label warns of possible preterm labor or spontaneous abortion during pregnancy. It also notes that medicines affecting gallbladder movement can interfere with the test response.
Product quality
Product identity and quality
Kinevac is supplied as a 5 mcg single-dose vial of powder for reconstitution and intravenous use.
Procedure and dose
Gallbladder contraction, pancreatic testing, and barium transit have different labeled schedules.
Infusion protocol
The 60-minute imaging-study method uses a different total dose from the labeled alternative gallbladder infusion.
Mechanism
How it is proposed to work
Sincalide acts like a portion of cholecystokinin, causing the gallbladder to contract and stimulating digestive secretions and intestinal movement.
The labeled drug is a synthetic C-terminal octapeptide of cholecystokinin.
Together with secretin, it increases pancreatic secretions available for diagnostic sampling.
Details
Technical details
Sources
References
- 1.
DailyMed. Kinevac (sincalide) prescribing information
US label for diagnostic use, intravenous dosing, contraindications, and adverse reactions.
- 2.
PubMed. Sincalide-stimulated cholescintigraphy: infusion methodology and gallbladder ejection fraction
doi:10.2967/jnumed.109.069393 PMID:20080900
Multicenter study comparing three infusion times in 60 healthy volunteers.
- 3.
Other. Sincalide infusion study full text
Full trial methods and funding disclosure.